medical Class II Updated 2019-09-25

Maquet Cardiovascular Us Sales, Llc recalls Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. M

Recalled Product

Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794

Hazard / Issue

The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.

Issued by

FDA

Affected States: AR, CA, FL, GA, IA, IL, IN, KY, NC, NE, NM, NV, NY, OH, OR, TN, WI
Lot/Code Info: Lot 70131093; UDI 04037691741543
View official government recall

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